Abstract | PURPOSE: DESIGN: Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. PARTICIPANTS: METHODS: MAIN OUTCOME MEASURES: The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT). RESULTS: Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 12.7 (9.9-15.4) and 14.9 (12.6-17.2) in the 0.3 mg and 0.5 mg ranibizumab groups, respectively, and 0.8 (-2.0 to 3.6) in the sham group (P<0.0001 for each ranibizumab group vs. sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 46.2% (0.3 mg) and 47.7% (0.5 mg) in the ranibizumab groups and 16.9% in the sham group (P<0.0001 for each ranibizumab group vs. sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg = 43.9%; 0.5 mg = 46.9%) had BCVA of > or = 20/40 compared with sham patients (20.8%; P<0.0001 for each ranibizumab group vs. sham), and CFT had decreased by a mean of 434 microm (0.3 mg) and 452 microm (0.5 mg) in the ranibizumab groups and 168 microm in the sham group (P<0.0001 for each ranibizumab group vs. sham). The median percent reduction in excess foveal thickness at month 6 was 94.0% and 97.3% in the 0.3 mg and 0.5 mg groups, respectively, and 23.9% in the sham group. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with CRVO. CONCLUSIONS:
|
Authors | David M Brown, Peter A Campochiaro, Rishi P Singh, Zhengrong Li, Sarah Gray, Namrata Saroj, Amy Chen Rundle, Roman G Rubio, Wendy Yee Murahashi, CRUISE Investigators |
Journal | Ophthalmology
(Ophthalmology)
Vol. 117
Issue 6
Pg. 1124-1133.e1
(Jun 2010)
ISSN: 1549-4713 [Electronic] United States |
PMID | 20381871
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Ranibizumab
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Double-Blind Method
- Endpoint Determination
- Female
- Follow-Up Studies
- Humans
- Injections
- Macular Edema
(drug therapy, etiology, physiopathology)
- Male
- Middle Aged
- Prospective Studies
- Ranibizumab
- Retinal Vein Occlusion
(complications, physiopathology)
- Treatment Outcome
- Visual Acuity
(physiology)
- Vitreous Body
- Young Adult
|